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Serious Adverse Events

Date of Publication:

3/9/2022

Definition:

An event that results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Source of Definition:

Use of Dietary Supplements in the DOD

Related Glossary Terms:

Adverse Event

Last Updated: February 05, 2024
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